NCT07427862

Brief Summary

The goal of this clinical trial is to to utilize Virtual Reality during their interventional radiology procedure to help reduce any pain and anxiety experienced during the procedure in patients above the age of 8 undergoing interventional radiology procedures. The main questions it aims to answer are:

  • To determine if Virtual Reality is more effective than standard care for reducing pain and anxiety in children undergoing painful interventional radiology procedures. It is hypothesized that children in the Virtual Reality condition will experience reduced pain and anxiety compared to children receiving standard of care.
  • To evaluate caregiver's assessment of patient distress and their satisfaction with Virtual Reality compared to standard of care. It is hypothesized that caregiver satisfaction with the medical procedure will be significantly greater in the Virtual Reality group compared to the standard of care group. It is hypothesized that caregivers will perceive lower pain/anxiety when their child receives Virtual Reality compared to standard of care. Participants will complete pre and post surveys before and after interventional radiology procedures. Participants will use Virtual Reality headsets while undergoing procedure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 17, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Virtual realityInterventional radiologyProcedural AnxietyPainPediatrics

Outcome Measures

Primary Outcomes (4)

  • Mean Change from baseline in Pain Intensity During Interventional Radiology Procedures

    Pain intensity will be assessed using the Faces Pain Scale - Revised (FPS-R), a validated self-report measure for children. The scale will be administered immediately before and after the intervention to evaluate changes in pain levels. Mean differences will be analyzed through paired samples t-test. 6 different faces representing various intensities of pain, ranging from "no pain" to "very much pain".

    Baseline to 1 hour post-intervention

  • Mean Change from baseline in Anxiety Intensity During Interventional Radiology Procedures

    Pain intensity will be assessed using the VAS Anxiety Scale and Childhood Anxiety Sensitivity Index (CASI), a validated self-report measure for children. The scale will be administered immediately before and after the intervention to evaluate changes in pain levels. Mean differences will be analyzed through paired samples t-test. scale from 1 - 10 with 10 being highest anxiety score.

    Baseline to 1 hour post-intervention

  • Mean satisfaction score for procedural success from caregivers.

    Caregiver satisfaction will be assessed using a validated satisfaction questionnaire. 1) Not at all well 5) Moderately well 10) Extremely well.

    1-hour post-intervention

  • Mean distress score with the medical procedure given to participants.

    Satisfaction survey scale of 1 (not at all well) to 10 (extremely well) how well procedure was managed.

    1-hour post-intervention

Other Outcomes (2)

  • Mean score in simulator sickness for participants.

    1-hour post-intervention

  • Mean score in virtual reality immersion for participants.

    1-hour post-intervention

Study Arms (1)

Use of Virtual Reality

Five minutes before the procedure and wear it throughout the procedure and can keep it on up to two minutes after procedure.

Device: Meta Oculus Quest ProDevice: Pico 4Device: Pico G3

Interventions

Participants 10 and older can use the Meta Oculus Quest Pro headset. The headset contains content that is appropriate for patients of 10 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Use of Virtual Reality
Pico 4DEVICE

Participants 8-18 can use the Pico 4 headset. The headset contains content that is appropriate for patients aged 8-18 with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Use of Virtual Reality
Pico G3DEVICE

Participants 13 and older can use the Pico G3 headset. The headset contains content that is appropriate for patients of 13 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Use of Virtual Reality

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and adult patients undergoing interventional radiology (IR) procedures at Children's Hospital Los Angeles (CHLA), along with legal guardians of participating pediatric patients

You may qualify if:

  • Children who are at least 8 years old
  • Children who are English speaking with caregivers who are English speaking or Spanish speaking.
  • Children who are undergoing an interventional radiology procedure are eligible to participate in this project.
  • Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

You may not qualify if:

  • Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
  • Children with a psychiatric disorder, organic brain syndrome, intellectual disability, or other known cognitive/neurological disorders
  • Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
  • Children with a history of seizure disorder.
  • Children currently sick with flu-like symptoms or experiencing a headache or earache.
  • Children with known or suspected motion sickness.
  • Children with cochlear implants or pacemakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey Gold, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff/USC Faculty CWR

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations